PDA Journal of Pharmaceutical Science and Technology最新文献

{"title":"High-Speed Radiographic Analysis of Subcutaneous Injection Depots: Dispersion, Morphology, and Diffusion in Autoinjector Delivery: Poster Presented at PDA Week 2025.","authors":"Rozhin Derakhshandeh, Jean-Christophe Veilleux, Galen H Shi, Pavlos P Vlachos","doi":"10.5731/pdajpst.2025.25401","DOIUrl":"https://doi.org/10.5731/pdajpst.2025.25401","url":null,"abstract":"<p><p>Autoinjectors facilitate self-administration of subcutaneous (SC) medications. Despite their benefits for patients and healthcare systems, experimental research on how they impact drug dispersion and absorption is limited. This study investigates how autoinjector injection parameters influence plume growth, morphology, and diffusion during and post injection. We investigated three commercial autoinjector models of a similar design with varying delivered volumes (0.5 mL, 1 mL, and 2 mL) injected into excised pork belly tissue. Synchrotron radiography provided high-resolution, real-time 2 D visualization of plume dynamics during injection, while the 3 D morphology of the depot postinjection was captured with a synchrotron CT. Our results show that plume growth is nonlinear, with an initial rapid phase slowing over time. The final plume volume exceeds the delivered dose by 25%, reflecting depot spread within the tissue. Regardless of autoinjector model or injection volume, the plume predominantly expands horizontally (parallel to the tissue), with the aspect ratio increasing throughout the injection and reaching a final value of approximately 4. Post-injection diffusion appears to be driven more by tissue properties than by the autoinjector design parameters. These findings provide a foundation for refining autoinjector designs, developing more accurate computational models to predict drug absorption, and optimizing SC delivery systems.</p>","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"79 4","pages":"424-425"},"PeriodicalIF":0.0,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144765177","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Material and Packaging Selection and Compatibility with Chlorine Dioxide Gas Sterilization: Poster Presented at PDA Week 2025.","authors":"Emily Lorcheim","doi":"10.5731/pdajpst.2025.25413","DOIUrl":"https://doi.org/10.5731/pdajpst.2025.25413","url":null,"abstract":"<p><p>Chlorine dioxide gas (CD) sterilization is an alternative modality to ethylene oxide as well as other sterilization modalities and is of high interest to the EPA and FDA due to both its sustainability as well as effectiveness. The dry method of generating chlorine dioxide gas was developed within Johnson and Johnson and generates a greater than 99% pure form of chlorine dioxide gas. CD gas is an oxidizer which is non-carcinogenic, non-explosive at use concentrations and can perform sterilization at ambient temperature. The presentation will discuss the elements that need to be considered when selecting packaging for a product being sterilized with chlorine dioxide gas. It includes an explanation of what packaging is most suitable for certain product categories as well as packaging suggestions for products with unique restrictions such as absorbable products. The poster will also include expert analysis from material manufacturers on test data on the suitability of chlorine dioxide with their materials. Additionally, residual levels and cytotoxity is analyzed to further indicate compatibility after processing.</p>","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"79 4","pages":"448-449"},"PeriodicalIF":0.0,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144765185","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"NeoFlex^TM Plunger Platform: A Focus on Large Volume Plungers for Autoinjector and Wearable Devices: Poster Presented at PDA Week 2025.","authors":"Yitian Xiao","doi":"10.5731/pdajpst.2025.25428","DOIUrl":"https://doi.org/10.5731/pdajpst.2025.25428","url":null,"abstract":"<p><p>Large-volume auto-injectors and wearable devices exceeding 2.25 mL play a crucial role in the transition from hospital-based intravenous (IV) treatments to self-administrated drug delivery via subcutaneous (SC) injection. These devices are especially pivotal in the treatment of oncological, immunologic, and neurodegenerative diseases, where they are often tasked with delivering high-viscosity and delicate biologics to patients in need. Ensuring the highest standards of quality and purity in elastomers, along with flawless functional performances, is imperative to guarantee the reliability of administration and patient safety. A balance of functionality, machinability, and product safety are essential for the entire device system to function. In this presentation, we will delve into the technical hurdles encountered in designing and manufacturing larger coated plungers for pre-filled syringe (PFS) and cartridge containers intended for device integration. We will showcase our journey from conceptualization to commercialization of these coated plungers, as well as evaluating their performance throughout the entire value chain to the patient. Additionally, we will underscore the significance of fostering an open collaboration with the container manufacturer and among the additional stakeholders involved in the development of the final combination product.</p>","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"79 4","pages":"478-479"},"PeriodicalIF":0.0,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144765188","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Quality Risk Management for Isolator Gloves.","authors":"Andreas Kindscher, Richard Denk, Chris Burns, Rico Schulze","doi":"10.5731/pdajpst.2025-000029.1","DOIUrl":"10.5731/pdajpst.2025-000029.1","url":null,"abstract":"<p><p>This article focuses on describing control measures intended to reduce the risk of glove damages, which can be linked to contamination (particulate or microbiological). Specific risks involving gloves are analyzed, assessed, and minimized by means of appropriate control measures. The aim is to demonstrate that the risk of contamination via isolator gloves cannot be mitigated by a single action, but rather that a combination of several preventative measures is required. Important control measures for the safe handling of gloves at barrier systems include the observation of glove functional use, personnel training, and monitoring control measures. This observation of the glove functional use can represent a higher or lower good manufacturing practice (GMP) risk for the product, depending on the intervention. The handling of the gloves and their use should be documented accordingly and evaluated in a risk assessment. The risk analysis defines measures that are part of the quality risk management for gloves and contribute to the safe production of sterile pharmaceuticals. This raises the question as to the point from which an isolator is at risk of microbiological contamination following damage to a glove, or what size of pinhole in a glove represents a risk. This article works on the assumption that this question can only be answered by means of glove quality risk management.</p>","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":" ","pages":"391-400"},"PeriodicalIF":0.0,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144310298","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Defining a Generic Technology Transfer Process for use Across the Biopharmaceutical Manufacturing Industry.","authors":"Jonathan Moore, Diana Chinchilla-Olszar, Mary Switzer, David Nellis, Dan Lasko, Ruth de la Fuente Sanz, Carrington Edmunds, Gene Schaeffer, Alex Gadberry, Jennifer Nicole Earley, Mithun N Thimonthy, Kelvin H Lee","doi":"10.5731/pdajpst.2024-003037.1","DOIUrl":"https://doi.org/10.5731/pdajpst.2024-003037.1","url":null,"abstract":"<p><p>The technology transfer process varies widely between organizations across the biopharmaceutical industry. This variation amplifies the complexity of transfers and negatively impacts the communication of critical information. Organizations tend to either have their own established inflexible processes or unclearly defined processes that change over time. This lack of standardization is compounded as individual companies redefine their processes to meet changing requirements. This creates inefficiencies and barriers to collaboration between organizations due to dissimilar technology transfer processes. Additionally, the industry is evolving rapidly with companies adopting new and novel processes (<i>e.g.,</i> continuous processing, new modalities) to meet the global demand for biopharmaceuticals. As the processes become more complex and divergent, the need for a generic technology transfer process increases. This National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) sponsored paper defines a generic technology transfer process using input from a broad range of subject matter experts from across the industry. This generic definition, which is not specific to any one company or any specific implementation, is provided as a starting point for organizations to build on in the future.</p>","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144643105","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Worldwide Regulatory Reliance: Results of an Executed Chemistry, Manufacturing, and Control Post-Approval Change Pilot.","authors":"Cynthia Ban, Jamie Graham, Lyne Le Palaire, Priya Persaud, Franziska Brehme, Olivier Faure, Allison Rameau, Ana Luisa Silva","doi":"10.5731/pdajpst.2024-003023.1","DOIUrl":"10.5731/pdajpst.2024-003023.1","url":null,"abstract":"<p><p>Post-approval changes (PACs) are integral to pharmaceutical product life cycle management, ensuring that the product remains safe, effective, and compliant with evolving standards. However, managing these changes across multiple regulatory jurisdictions remains a challenging endeavor due to diverse regulatory requirements and timelines across national regulatory authorities (NRAs). This results in delays in obtaining approval from NRAs, impacting global supply chains and ultimately jeopardizing timely access to essential medical products by patients. In 2021, the World Health Organization issued the Good Reliance Practices (GReIP) guidance to encourage streamlined PAC review and approval process while maintaining access to quality-assured, safe, and effective medicinal products. NRAs are encouraged to rely on the assessment completed by a reference authority that agrees to provide the outcomes of its regulatory expertise. The ultimate objective of this guidance is to accelerate the overall process for PACs, ultimately fostering more equitable and timely access to medical products by the populations who need them. This approach was tested in a chemistry, manufacturing, and control PAC pilot to determine the feasibility of using the principles of regulatory reliance based on the recommendations outlined in the GReIP with the goal of establishing a predictable, 6-month approval timeframe across multiple NRAs. The design and management of this pilot is described in Gastineau et al. This paper describes the outcomes of the pilot, which demonstrated that regulatory reliance is feasible. Of the 21 NRAs that agreed to participate, 55% were able to complete the review within 6 months; within 10 months, 95% of approvals were received and, after 16 months, all participating countries had approved the PAC. The use of a Q&A SharePoint Tool allowed for visibility of the questions raised and the company responses among the NRAs. Feedback on this reliance pilot was solicited from the participating NRAs and provides further support for future CMC PAC reliance cases.</p>","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":" ","pages":"295-302"},"PeriodicalIF":0.0,"publicationDate":"2025-06-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144028288","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Mechanical Container Closure Integrity Test: A Method for Cartridge Systems.","authors":"Michael W Foubert, Benoit Lux, Julie Bourguard, Lucas Schultz, Meng John Zhao, Jason D Marlin, Matthew S Huser, Henri Hebting, Lei Li","doi":"10.5731/pdajpst.2024.012941","DOIUrl":"10.5731/pdajpst.2024.012941","url":null,"abstract":"<p><p>A cartridge container closure integrity control strategy may leverage a combination of test methods to ensure that drug products in the assembled container system are protected from an exchange with the external environment. These methods provide evidence supporting the suitability of the container closure system; however, some methods involve extended test times, complex setups, subjective interpretation, and are destructive. A method that mitigates such factors was developed to improve upon testing utilized within the control strategy. Reviewing the underlying principles of internal methods and external standards resulted in two potential paths, a force decay method and a constant force method, to improve on the cartridge control strategy using a linear mechanical testing system. The force decay method monitors the force decay signal obtained from applying a predetermined force and holding the displacement constant for a desired time frame. The constant force method monitors the displacement signal obtained from applying a predetermined force and holding the force constant for a desired time frame. Supplementing the experimental data generated by both methods with a finite element analysis along with a first principles derivation of the system response aided in a recommendation to utilize the constant force method for cartridge container closure integrity leak testing. The constant force method was then optimized to attain the best signal response for leak detection and ensure a robust method. The data generated in this article support the viability of using the constant force mechanical container closure integrity test method for improving the in-process container closure integrity testing strategy for solution products.</p>","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":" ","pages":"303-319"},"PeriodicalIF":0.0,"publicationDate":"2025-06-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144023092","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Viral Safety Reloaded-Insights from PDA's Virus Conference Around the Finalized ICH Q5A (R2) and NGS Workshop.","authors":"Sebastian B Teitz, Andy Bailey, Johannes Blümel, Arifa Khan, Alison Armstrong, Thomas R Kreil, Tomoko Hongo-Hirasaki, Remo Leisi, David Cetlin, Chakameh Azimpour, Sean O'Donnel, Simone Olgiati","doi":"10.5731/pdajpst.2025-000009.1","DOIUrl":"https://doi.org/10.5731/pdajpst.2025-000009.1","url":null,"abstract":"","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"79 3","pages":"337-354"},"PeriodicalIF":0.0,"publicationDate":"2025-06-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144209123","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"PDA Journal Editorial Board-An Update.","authors":"Mike Sadowski","doi":"10.5731/pdajpst.2025.001943","DOIUrl":"https://doi.org/10.5731/pdajpst.2025.001943","url":null,"abstract":"","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"79 3","pages":"250-251"},"PeriodicalIF":0.0,"publicationDate":"2025-06-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144209122","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Coring and Fragmentation of Elastomeric Needle Shield in a Pre-Filled Syringe.","authors":"Sahab Babaee, Sean Teller, Kavin Kowsari, Nikolaos Vasios, Steven C Persak, Nagi Elabbasi, Guangli Hu","doi":"10.5731/pdajpst.2024-003041.1","DOIUrl":"10.5731/pdajpst.2024-003041.1","url":null,"abstract":"<p><p>Elastomeric components such as closures and stoppers play key roles in providing container closure integrity (CCI), supporting a portfolio of injectable combination products and primary containers including needle shields (NSs) in prefilled syringes (PFSs). Upon piercing through the elastomeric (i.e., synthetic rubber) components, the physical interaction between the needle and the deformable elastomer could result in the formation of small, random-shaped particles fragmented and dislodged from the NS material due to cutting processes. This phenomenon, called coring, poses a major risk in drug product contamination, as elastomer particle fragments can potentially be aspirated with the medication and injected into a patient or prevent injection. Here, we present a combined computational and experimental approach to assess the incidence of coring. In particular, we first experimentally characterized the nonlinear finite deformation behavior of five commonly used NS elastomers and calibrated constitutive models. Then, we performed finite element simulations validated with needle insertion experiments to compare the coring behavior of the NS elastomers. We demonstrated that higher maximum failure strain under tension and higher deformation-stiffening properties of the elastomer are contributing factors that attenuate coring and fragmentation. The experimental-numerical framework presented is suitable for quantifying broad correlative and discovering relationships between device properties governing the incidence of coring and fragmentation.</p>","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":" ","pages":"274-284"},"PeriodicalIF":0.0,"publicationDate":"2025-06-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144037956","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}